Summary:

Photodynamic therapy (PDT) is a combination of a drug, porfimer sodium (Photofrin), which is
activated by a light from a laser that emits no heat. This technique works to allow the
medical doctor to specifically target and destroy abnormal or cancer cells while limiting
damage to surrounding healthy tissue. The activation of the drug is done by lighting the
abnormal areas using a fiber optic device (very fine fiber like a fishing line that permits
light transmission) inserted into a flexible tube with a light called cholangioscope for the
bile duct. The light will activate the porfimer sodium concentrated in the abnormal tissue,
leading to its destruction.
This research study will evaluate the efficacy and safety of PDT with porfimer sodium
administered with Standard Medical Care (SMC) compared to SMC alone on the overall survival
time of patients with non-operable advanced cholangiocarcinoma, a rare cancer of the bile
ducts. It will involve 200 patients across North America and Europe. Other countries may
participate if needed. Participation will last at least 18 months.

Trial Description

Primary Outcome:

Overall survival

Secondary Outcome:

Time-to-bilirubin response

Best overall tumour response

Time-to-tumour progression

Change from baseline in performance status on the Karnofsky Performance Scale (KPS)

Change from baseline in health-related quality of life on the 4- and 7-point European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30)

Change from baseline in health-related quality of life on the 4- and 7-point EORTC QLQ-C30